Clinical trial · Interventional
Study of Low Intensity Conditioning and Immunotherapy for High-Risk Cancers of the Blood
Adjuvant Cellular Immunotherapy for High-Risk Hematologic Malignancy After Allogeneic Stem Cell Transplantation Using Low Intensity Conditioning
NCT00143884CI-TRIAL-00000697terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This research project will focus on whether it is safe and effective to rely on donor cells to prevent relapse of leukemia, lymphoma, or other blood cancer after bone marrow stem cell transplant.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma, Low-Grade | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Non-Hodgkin's | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic donor leukocyte infusions | Procedure | — | UNRESOLVED |
| Reduced intensity conditioning | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To conduct a phase I-II trial of prophylactic cellular immunotherapy after allogeneic hematopoietic stem cell therapy using low intensity conditioning for high-risk hematological malignancies
Secondary outcomes (1)
- measure
- To evaluate both surrogate markers of GVHD (with a cytokine panel) and minimal residual disease and correlate these with clinical outcomes during the above trial
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Patient Inclusion Criteria:
* One of the following hematological malignancies:
1. Chronic myelogenous leukemia
1. Accelerated phase
2. Blast phase
2. Acute myelogenous leukemia
1. First or greater complete remission if high risk features: abnormalities of chromosomes with known poor prognosis 5 or 7.
2. Relapsed or refractory patients with ≤ 30% blasts
3. Aged 55 years or older in any disease state beyond first remission if blast percentage is \< 30%.
3. Acute lymphoblastic leukemia
1. First complete remission if high risk features: t(4;11)
2. Second complete remission if relapse occurs within the first 12 months of therapy
3. Third or greater complete remission
4. Relapsed or refractory patients with ≤ 30% blasts
5. Aged 55 years or old in second in any disease state beyond first remission if blast percentage is \< 30%.
4. Myelodyplastic syndromes
1. RAEB or RAEB-t patients, 55 years of age or older
2. Any hematologic malignancy relapsed following autologous or matched related donor allogeneic stem cell transplant provided at least 90 days has elapsed from most recent transplant
5. Non-Hodgkin's Lymphoma
1. 55 years or older, who have failed anthracycline containing regimen and do not have any tumor larger than 5 cm in diameter.
2. Patients with rapidly progressive disease are ineligible.
6. Multiple myeloma patients, any age, who meet at least one of the following criteria:
1. disease refractory to conventional chemotherapy such as VAD, pulse decadron, or alkylating agents, OR
2. chromosomal abnormality by cytogenetics or FISH probe.
7. Chronic lymphoblastic leukemia patients
1. Any age
2. Advanced disease (Rai stage 3 or 4)
3. Relapsed following/refractory to alkylating agents or nucleoside analog therapy
4. NOTE: Patients with bulky disease (lymphadenopathy \> 5 cm) or progressive disease NOT eligible.
8. Mantle cell lymphoma
1. Any age
2. Disease stage 3 or 4
3. Lymphadenopathy must not exceed 5 cm in any dimension
9. Any eligible disease category, any age, if ineligible for myeloablative conditioning because of organ dysfunction or advanced age (55 years or older). Minimum organ function for patients entered on this protocol defined as:
1. Cardiac: Ejection fraction at least 30%.
2. Renal: Creatinine \<1.5 times normal for age.
3. Pulmonary: FEV1 and FVC \>60%.
4. Hepatic: Total bilirubin \<2.0 and AST/ALT \<3 X institutional normal for age.
5. Performance (adults): Karnofsky score must be at least 60; for pts. under 16, Lansky score must be at least 60.
10. Low grade lymphoma (small lymphocytic, follicular small cleaved cell, or follicular mixed small cleaved and large cell) must meet the following criteria:
1. any age
2. relapsed or refractory disease provided the disease is NOT rapidly progressive
3. no lymphoma mass or lymph node exceeds 5 cm in greatest dimension
* Age: no age restriction
* Availability of a 6/6 HLA A, B, and DR identical relative who is willing and able to donate allogeneic stem cells
* No active infection
* Serum creatinine less than 1.5 times normal for age
* Serum bilirubin less than 1.5 times normal for age
* Not pregnant.
Patient Exclusion Criteria:
* HIV positive patients not eligible
* Pregnant
Donor Inclusion Criteria:
* 6/6 HLA match for HLA-A, B, and DR
* Age 3-70 years, good general health
* No contraindication to G-CSF stimulation
* No contraindication to leukapheresis of peripheral blood stem cells
* Good general health
Donor Exclusion Criteria:
* HIV positive or history of HIV risk factors
* Presence of other diseases transmissible by blood that pose unacceptable risk to the study subject.
* Pregnant
* Medical or psychological conditions that would make the donor unlikely to tolerate G-CSF injections or leukapheresisReferences
Publications (0)
Data not yet available
No reference posted for this study.